S&C-SELF ETCH PR-BOND— 510(k) K042614

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K042614 for S&C-SELF ETCH PR-BOND, Substantially Equivalent on 2004-11-22. Applicant: S & C Polymer GmbH. Device class: 2.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2004-09-24
Decision date: 2004-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from S & C Polymer GmbH

K091735 — DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT2009-09-25
K083062 — ROOT CANAL XR2009-03-12
K083766 — PHOGLASS CEM2009-03-02
K082115 — PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT2009-01-15
K081702 — CARBOXYLATE CEM, PHOSPHATE CEM2008-09-05

Recalls naming K042614

K-number listed on FDA's recall record

Z-2128-2014 — Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.Class II·Terminated·Novocol, Inc.·20140716
Z-2129-2014 — Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.Class II·Terminated·Novocol, Inc.·20140716

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042614.

Data sourced from openFDA. This site is unofficial and independent of the FDA.